Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases.
Journal
Drugs - real world outcomes
ISSN: 2199-1154
Titre abrégé: Drugs Real World Outcomes
Pays: Switzerland
ID NLM: 101658456
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
accepted:
14
05
2021
pubmed:
30
7
2021
medline:
30
7
2021
entrez:
29
7
2021
Statut:
ppublish
Résumé
Anthroposophic medicinal products (AMPs) are widely used in Europe and world-wide. To determine the frequency of reported adverse drug reactions (ADRs) from all AMPs on the market, in absolute numbers and relative to the maximum daily administration doses (MDADs). Retrolective safety analysis of AMP-related ADRs in pharmacovigilance databases of four AMP Marketing Authorisation Holders in Germany. For each ADR, information about the patient, outcome, causality and AMP was retrieved. Primary outcome was the frequency of reported ADRs relative to MDADs sold. In the period 2010-2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different AMPs. A total of 104 ADRs (1.9%) were classified as serious. The frequency of ADRs for all AMPs was 1.50 per million MDADs. For serious ADRs the frequency was 0.03 per million MDADs. ADRs were more frequently reported with parenteral AMP administration (injections) than with oral or local administration (18.85 vs. 0.59 vs. 1.61 ADRs per million MDADs, respectively; p < 0.0001). The large majority of users (91.9%) had recovered or were recovering from the ADRs and there were no reports with a fatal outcome. Most frequently reported ADR symptom was injection site inflammation for parenteral AMPs (4.66 ADRs per million MDADs), nausea for oral AMPs (0.03 ADRs per million MDADs), and eye irritation for locally administered AMPs (0.23 ADRs per million MDADs). In this retrolective safety analysis of pharmacovigilance data, the frequency of ADRs to AMPs was 1.50 per million MDADs. Notably, the ADR frequency in this study based on spontaneous reporting is not directly comparable to frequencies in prospective clinical studies nor to frequencies based on other measures of patient exposure than MDADs.
Sections du résumé
BACKGROUND
BACKGROUND
Anthroposophic medicinal products (AMPs) are widely used in Europe and world-wide.
OBJECTIVE
OBJECTIVE
To determine the frequency of reported adverse drug reactions (ADRs) from all AMPs on the market, in absolute numbers and relative to the maximum daily administration doses (MDADs).
PATIENTS AND METHODS
METHODS
Retrolective safety analysis of AMP-related ADRs in pharmacovigilance databases of four AMP Marketing Authorisation Holders in Germany. For each ADR, information about the patient, outcome, causality and AMP was retrieved. Primary outcome was the frequency of reported ADRs relative to MDADs sold.
RESULTS
RESULTS
In the period 2010-2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different AMPs. A total of 104 ADRs (1.9%) were classified as serious. The frequency of ADRs for all AMPs was 1.50 per million MDADs. For serious ADRs the frequency was 0.03 per million MDADs. ADRs were more frequently reported with parenteral AMP administration (injections) than with oral or local administration (18.85 vs. 0.59 vs. 1.61 ADRs per million MDADs, respectively; p < 0.0001). The large majority of users (91.9%) had recovered or were recovering from the ADRs and there were no reports with a fatal outcome. Most frequently reported ADR symptom was injection site inflammation for parenteral AMPs (4.66 ADRs per million MDADs), nausea for oral AMPs (0.03 ADRs per million MDADs), and eye irritation for locally administered AMPs (0.23 ADRs per million MDADs).
CONCLUSIONS
CONCLUSIONS
In this retrolective safety analysis of pharmacovigilance data, the frequency of ADRs to AMPs was 1.50 per million MDADs. Notably, the ADR frequency in this study based on spontaneous reporting is not directly comparable to frequencies in prospective clinical studies nor to frequencies based on other measures of patient exposure than MDADs.
Identifiants
pubmed: 34322827
doi: 10.1007/s40801-021-00262-7
pii: 10.1007/s40801-021-00262-7
pmc: PMC8605942
doi:
Types de publication
Journal Article
Langues
eng
Pagination
589-601Informations de copyright
© 2021. The Author(s).
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